Nearly 12 Million Rohto Eye Drop Cartons Recalled Nationwide Over Sterility Concerns

Over-the-counter eye care brand Rohto is recalling nearly 12 million cartons of cooling eye drops across the United States after federal regulators warned the products may lack proper sterility assurance.

The voluntary recall affects 11,960,623 cartons of Rohto Cooling Eye Drops distributed nationwide, according to an FDA enforcement report. The issue stems from concerns that the drops cannot be guaranteed free of potential microbial contaminants. Ophthalmic solutions require strict manufacturing oversight, as unsterile eye products introduce risks of bacterial or fungal eye infections.

Eight specific product formulations packaged in both single and twin-pack configurations fall under the recall scope, including Rohto Cooling Eye Drops in ALL-IN-ONE, Max Strength, Optic Glow, Digi Eye, Dry Aid, and Cool Relief varieties. The affected units feature expiration dates spanning between July 2025 and February 2029.

Federal health authorities classified the action as a Class II recall. Under FDA regulatory standards, a Class II designation indicates that exposure or use of the product may trigger temporary or medically reversible health issues, while the risk of serious adverse health outcomes remains low.

The eye drops were manufactured by Rohto-Mentholatum in Vietnam and distributed across the U.S. market by Orchard Park, New York-based The Mentholatum Company.

Regulators advise consumers holding any affected items to stop using them immediately. Products can be safely discarded or returned to the original point of purchase for a full refund. Consumers can verify whether their packaging is included by matching lot numbers and expiration dates against recall announcements on the manufacturer’s notice or official FDA databases.

The Rohto action follows other notable pharmaceutical product recalls in recent months. Lupin Pharmaceuticals Inc. recently initiated a Class II recall of 2,530,182 bottles of prednisolone acetate ophthalmic suspension USP, 1%, a prescription steroid eye medication, after foreign particulate matter was identified in specific lots. Separately, certain lots of generic cetirizine hydrochloride tablets, commonly sold as generic Zyrtec, were pulled due to potential drug cross-contamination risks capable of causing severe adverse reactions.